Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
Primary Purpose
Barrett Esophagus, Gastric Antrectomy Partial, Biliary Duct Stricture
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Confocal endomicroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett Esophagus
Eligibility Criteria
Inclusion Criteria:
- Minimum age of 18 years old
- Clinical conditions for the proposed endoscopic procedure
- Sign the informed consent
Exclusion Criteria:
- History of anaphylactic reactions to fluorescein
Sites / Locations
- Instituto do Câncer do Estado de São Paulo - ICESP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Confocal endomicroscopy
Arm Description
Pts will be submitted to confocal endomicroscopy examination of the area of interest during endoscopy. A presumptive diagnosis will be made. This diagnosis will be compared to the definitive histologic diagnosis provided by endoscopic biopsies of the area of interest.
Outcomes
Primary Outcome Measures
accuracy of confocal endomicroscopy
Diagnostic accuracy of confocal endomicroscopy for the early detection of tumors of the digestive tract
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02284802
Brief Title
Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
Official Title
Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2014 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fauze Maluf Filho
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Confocal endomicroscopy is an emerging technique that allows in vivo imaging of cells and tissue structures of the gastrointestinal mucosa, with a magnification of about 1000 times, guiding optical biopsies in real time. Confocal endomicroscopy represents technique that combines conventional white light image with the confocal microscope probe, thereby allowing examination of the surface epithelium in vivo and histological diagnosis during endoscopy. Among the applications already established for its use, stand out diagnosis of Barrett's esophagus, gastric atrophy and intestinal metaplasia, celiac disease, differentiation of hyperplastic adenomatous polyps of the colon, microscopic colitis and follow-up of patients with inflammatory disease, reducing the need for endoscopic biopsies. The CLE can still detect molecular changes effectively improving the endoscopic diagnosis. This pilot project consists of 07 subprojects which the technology of confocal endomicroscopia will be evaluated and compared with the histological results of biopsy or surgical specimens:
1. confocal endomicroscopy for the diagnosis of high-grade dysplasia and superficial esophageal adenocarcinoma in patients with Barrett's esophagus 2 Diagnosis of superficial esophageal squamous cell carcinoma in patients with head and neck cancer by confocal endomicroscopy 3 Detect the presence of premalignant lesions in the gastric stump in patients with reflux alkaline gastritis after partial gastrectomy 4. detect lesions in the gastric mucosa of patients with familial history of gastric cancer 5 Biliary Strictures: differential diagnosis by confocal endomicroscopia 6 confocal Endomicroscopy of cystic neoplasms of the pancreas 7 Contribution of confocal endomicroscopy for the differential diagnosis of colorectal polyps The project aims to deploy the structure of the Confocal endomicroscopy Endoscopy ICESP, for performing in vivo histological examinations of the digestive tract, biliary tract and pancreas. All research groups involved in the early detection of tumors of the esophagus, stomach, biliary tract, pancreas, colon and rectum may benefit from the implementation of this methodology.
Detailed Description
Confocal Endomicroscopy procedure: eligible patients which consent to participate in the study will be submitted to endoscopic procedures under conscious or deep sedation. The patients will receive an intravenous injection of 2.5-5 mL of 10% sodium fluorescein at the beginning of the endoscopic procedure. The endoscope will target the area of interest and the confocal probe will be passed through the endoscope biopsy channel. The probe will gently and perpendicularly touch the mucosal surface of the area of the interest. The images will be recorded and a presumptive diagnosis will be made. The area of interest will be biopsied and the histology results will be considered the diagnostic gold standard method. We will calculate the diagnostic accuracy of the presumptive diagnosis provided by the confocal endomicroscopy examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Gastric Antrectomy Partial, Biliary Duct Stricture, Pancreatic Duct Stricture, Colorectal Polyps, Esophageal Neoplasms, Head and Neck Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Confocal endomicroscopy
Arm Type
Experimental
Arm Description
Pts will be submitted to confocal endomicroscopy examination of the area of interest during endoscopy. A presumptive diagnosis will be made. This diagnosis will be compared to the definitive histologic diagnosis provided by endoscopic biopsies of the area of interest.
Intervention Type
Procedure
Intervention Name(s)
Confocal endomicroscopy
Intervention Description
Confocal endomicroscopy examination during endoscopy
Primary Outcome Measure Information:
Title
accuracy of confocal endomicroscopy
Description
Diagnostic accuracy of confocal endomicroscopy for the early detection of tumors of the digestive tract
Time Frame
Less than 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum age of 18 years old
Clinical conditions for the proposed endoscopic procedure
Sign the informed consent
Exclusion Criteria:
History of anaphylactic reactions to fluorescein
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fauze Maluf-FIlho, MD, PHD
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Câncer do Estado de São Paulo - ICESP
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27697445
Citation
Safatle-Ribeiro AV, Baba ER, Faraj SF, Rios JT, de Lima MS, Martins BC, Geiger SN, Pennacchi C, Gusman C, Kawaguti FS, Uemura RS, de Melo ES, Ribeiro U Jr, Maluf-Filho F. Diagnostic accuracy of probe-based confocal laser endomicroscopy in Lugol-unstained esophageal superficial lesions of patients with head and neck cancer. Gastrointest Endosc. 2017 Jun;85(6):1195-1207. doi: 10.1016/j.gie.2016.09.031. Epub 2016 Sep 30.
Results Reference
result
PubMed Identifier
30510366
Citation
Safatle-Ribeiro AV, Ryoka Baba E, Corsato Scomparin R, Friedrich Faraj S, Simas de Lima M, Lenz L, Costa Martins B, Gusmon C, Shiguehissa Kawaguti F, Pennacchi C, Zilberstein B, Ribeiro U Jr, Maluf-Filho F. Probe-based confocal endomicroscopy is accurate for differentiating gastric lesions in patients in a Western center. Chin J Cancer Res. 2018 Oct;30(5):546-552. doi: 10.21147/j.issn.1000-9604.2018.05.08.
Results Reference
result
PubMed Identifier
26949002
Citation
Baba ER, Safatle-Ribeiro AV, Paduani GF, Giovannini M, Maluf-Filho F. Probe-based confocal laser endomicroscopy for the differential diagnosis of gastric tubular adenoma and intestinal metaplasia in a patient with severe atrophic pangastritis. Gastrointest Endosc. 2016 Jul;84(1):183. doi: 10.1016/j.gie.2016.02.033. Epub 2016 Mar 3. No abstract available.
Results Reference
result
PubMed Identifier
33443686
Citation
Safatle-Ribeiro AV, Marques CFS, Pires C, Arraes L, Baba ER, Meirelles L, Kawaguti FS, da Costa Martins B, Lenz LT, de Lima MS, Gusmon-Oliveira CC, Ribeiro U Jr, Maluf-Filho F, Nahas SC. Diagnosis of Clinical Complete Response by Probe-Based Confocal Laser Endomicroscopy (pCLE) After Chemoradiation for Advanced Rectal Cancer. J Gastrointest Surg. 2021 Feb;25(2):357-368. doi: 10.1007/s11605-020-04878-y. Epub 2021 Jan 14.
Results Reference
result
PubMed Identifier
30517234
Citation
Scomparin RC, Bento LH, Batista CP, Martins BC, Lenz L, Baba ER, Safatle-Ribeiro AV, Maluf-Filho F. Application of confocal endomicroscopy in the diagnostic elucidation of pancreatic cyst. Rev Assoc Med Bras (1992). 2018 Oct;64(10):885-887. doi: 10.1590/1806-9282.64.10.885. No abstract available.
Results Reference
result
PubMed Identifier
29905177
Citation
Bastos VR, Safatle-Ribeiro AV, Baba ER, da Costa Martins B, Maluf-Filho F. The impact of probe-based confocal endomicroscopy on the management of indeterminate bile duct strictures. VideoGIE. 2017 Dec 9;3(1):26-27. doi: 10.1016/j.vgie.2017.10.003. eCollection 2018 Jan. No abstract available.
Results Reference
result
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Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
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